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Quality System Overview

NMRA · NMRA Act No. 5 of 2015 · ISO 13485 · GMP

Overview​

Sri Lanka requires evidence of quality management system compliance as part of both the manufacturing site registration and the device registration dossier. The NMRA accepts internationally recognised standards and inspection reports from recognised reference authorities.

QMS Requirements by Entity​

EntityRequirement
Foreign manufacturerISO 13485 certificate covering the manufacturing site + manufacturing site registration with NMRA
Local manufacturerNMRA GMP inspection and manufacturing licence
MAH / local importerGDP-aligned storage and distribution practices

ISO 13485 — Core QMS Standard​

ISO 13485 is the primary QMS standard accepted by NMRA. Requirements:

  • Certificate from an internationally accredited certification body
  • Scope must cover the device category being registered
  • Current at time of submission and throughout registration validity
  • Updated certificate required at renewal

The ISO 13485 certificate is submitted in the consolidated dossier (F-MDR-035) as part of the technical documentation package.

Manufacturing Site Registration — LK-Unique​

NMRA requires separate registration of the manufacturing site as a prerequisite before or alongside device registration. The manufacturing site registration involves:

  1. Submission of a Site Master File (SMF) describing the facility, manufacturing processes, QMS, and quality control arrangements
  2. On-site GMP inspection by NMRA inspectors — or a waiver if inspection by a recognised NRA (see below)
  3. NMRA site approval — valid for a defined period

Manufacturing site registration must be current throughout the device registration period.

Inspection Waiver for Recognised NRAs — LK-Unique​

NMRA may waive the on-site inspection if the manufacturing site has already been inspected by one of the following recognised NRAs:

  • Australia (TGA)
  • Canada (Health Canada)
  • European Union (relevant Notified Body or National CA)
  • Japan (PMDA / MHLW)
  • United States (FDA)
  • United Kingdom (MHRA)
  • Switzerland (Swissmedic)
  • WHO pre-qualification (for certain categories)

Provide the inspection report or GMP certificate from the recognised NRA as evidence. NMRA will assess whether the inspection is recent enough and covers the relevant product scope.

GMP Content — What the Site Must Demonstrate​

During site registration (inspection or waiver-supported), the facility must demonstrate:

  • Facility design and environmental controls
  • Equipment qualification, calibration, and maintenance
  • Personnel training and competency records
  • Document control and batch record systems
  • Production and process controls
  • Supplier qualification
  • Quality control testing
  • Internal audit programme
  • CAPA system
  • Complaint handling procedures

GDP for MAHs and Distributors​

The MAH and distributors must maintain good distribution practice:

  • Appropriate storage conditions (temperature and humidity monitoring where required)
  • Segregation of approved, quarantined, and rejected stock
  • Distribution records enabling traceability from receipt to end customer (hospitals, pharmacies, clinics)
  • FIFO stock rotation

These practices are reviewed by the NMRA Market Control Division.

Maintaining QMS Compliance Post-Registration​

  • Submit updated ISO 13485 certificates at renewal
  • Notify NMRA if the manufacturing site's ISO 13485 certification is suspended or withdrawn
  • If the manufacturing site changes, a new site registration may be required — confirm with NMRA
  • Significant changes to the QMS (major facility renovation, new manufacturing processes) should be communicated to NMRA